NCT00569686 is a NA clinical trial of lovaza in Peripheral Artery Disease, sponsored by University of Virginia.

Who is sponsoring NCT00569686?

NCT00569686 is sponsored by University of Virginia.

What drugs are being tested in NCT00569686?

Interventions in NCT00569686: lovaza, placebo.

What condition does NCT00569686 study?

NCT00569686 studies Peripheral Artery Disease.

Is NCT00569686 still recruiting?

NCT00569686 is currently withdrawn. Last updated 1 May 2018.

Last reviewed 2018-05-01 · How we verify

NCT00569686

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Lovaza Therapy of Peripheral Arterial Disease

Withdrawn NA Last updated 1 May 2018

What this trial tests

NA trial testing lovaza in Peripheral Artery Disease. Withdrawn.

Timeline

1 September 2007

Primary endpoint
1 December 2009

1 February 2010

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 September 2007
Primary completion	1 December 2009
Estimated completion	1 February 2010
Sites	1 location across United States

Drugs / interventions tested

lovaza — full drug profile →
placebo

Conditions studied

Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

University of Virginia

Who can join

Adults 40 to 80, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce or prevent progression of atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year as compared to placebo.
Time frame: one year

Sponsor's own description

Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (\>200 mg/dl) already treated with statins will be imaged at baseline and randomized to Lovaza and placebo for 12 months. MR imaging will be repeated at the end of the 12-month period. We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year compared to placebo. Secondary aims will be to show improved plaque characteristics (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance with Lovaza compared to matching placebo.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of lovaza

Trials testing the same drug.

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NCT03329248 — QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic C · Phase 1, PHASE2 · terminated

Other recruiting trials for Peripheral Artery Disease

Currently open trials in the same condition.

NCT07374601 — The Value of Super-resolution Ultrasound Imaging for Peripheral Artery Disease · recruiting
NCT06686121 — Improving Mobility After Revascularization in Peripheral Artery Disease · Phase 3 · recruiting
NCT04433572 — Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee · Phase 3 · recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT07012070 — Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers · NA · recruiting

Other University of Virginia trials

Trials by the same sponsor.

NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
NCT07036315 — Meaning in Music-Based Pain Modulation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00569686 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 1 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00569686.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing